Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 and over	Pharmaceutical / Industry	GPI-06-0002 NCT00426764

Trial Description

Summary

The purpose of this study is to evaluate the activity of romidepsin in patients with progressive or relapsed peripheral T-cell lymphoma (PTCL) who have already been treated with systemic therapy.

Patients will receive romidepsin intravenously (through a vein) over 4 hours on Days 1, 8 and 15 of each 28-day cycle.

The planned duration of study treatment is 6 cycles or until disease progression occurs.

Eligibility Criteria

Inclusion Criteria:

Patients must fulfill all of the following criteria to be eligible for study participation and have:

• Histologically confirmed PTCL NOS, angioimmunoblastic T-cell lymphoma, extranodal NK/T-cell lymphoma nasal type, enteropathy- type T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, cutaneous T-cell lymphoma (excludes mycosis fungoides or Sezary syndrome), transformed mycosis fungoides, hepatosplenic T-cell lymphoma, ALCL (ALK-1 negative), or patients with ALK 1 expressing ALCL (ALK-1 positive) who have relapsed disease after ASCT;

• Age ≥18 years;

• Written informed consent;

• PD following at least one systemic therapy or refractory to at least one prior systemic therapy;

• Measurable disease according to the IWC criteria and/or measurable cutaneous disease;

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;

• Serum potassium ≥3.8 mmol/L and magnesium ≥0.85 mmol/L (electrolyte abnormalities can be corrected with supplementation to meet inclusion criteria);

• Negative urine or serum pregnancy test on females of childbearing potential; and

• All women of childbearing potential must use an effective barrier method of contraception (either an intrauterine contraceptive device [IUCD] or double barrier method using condoms or a diaphragm plus spermicide) during the treatment period and for at least 1 month thereafter. Male patients should use a barrier method of contraception during the treatment period and for at least 1 month thereafter. Hormonal methods of contraception such as the contraceptive pill or patch (particularly those containing ethinyl-estradiol) should be avoided due to a potential drug interaction.

Exclusion Criteria:

Patients are ineligible for entry if any of the following criteria are met:

• Known central nervous system (CNS) lymphoma [computed tomography (CT) or magnetic resonance imaging (MRI) scans are required only if brain metastasis is suspected clinically];

• Chemotherapy or immunotherapy within 4 weeks of study entry (6 weeks if nitrosoureas given);

• Concomitant use of any other anti-cancer therapy;

• Concomitant use of any investigational agent;

• Use of any investigational agent within 4 weeks of study entry;

• Any known cardiac abnormalities such as:

• Congenital long QT syndrome;

• QTc interval >480 milliseconds (msec);

• A myocardial infarction within 6 months of C1D1. Subjects with a history of myocardial infraction between 6 and 12 months prior to C1D1 who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate;

• Other significant ECG abnormalities including 2nd atrio-ventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min).

• Symptomatic coronary artery disease (CAD), e.g., angina Canadian Class II-IV. In any patient in whom there is doubt, the patient should be referred to a cardiologist for evaluation;

• An ECG recorded at screening showing significant ST depression (ST depression of ≥2 mm, measured from isoelectric line to the ST segment at a point 60 msec at the end of the QRS complex). If in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present;

• Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II to IV definitions and/or ejection fraction <40% by MUGA scan or <50% by echocardiogram and/or MRI;

• A known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD);

• Hypertrophic cardiomyopathy or restrictive cardiomyopathy from prior treatment or other causes (if in doubt, see ejection fraction criteria above);

• Uncontrolled hypertension, i.e., blood pressure (BP) of ≥160/95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria;

• Any cardiac arrhythmia requiring anti-arrhythmic medication;

• Serum potassium <3.8 mmol/L or serum magnesium <0.85 mmol/L (electrolyte abnormalities can be corrected with supplementation to meet inclusion criteria);

• Concomitant use of drugs that may cause a prolongation of the QTc;

• Concomitant use of CYP3A4 significant or moderate inhibitors;

• Concomitant use of therapeutic warfarin or another anticoagulant due to a potential drug interaction. Use of a small dose of a anticoagulant to maintain patency of venous access port and cannulas is permitted;

• Clinically significant active infection;

• Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C;

• Previous extensive radiotherapy involving ≥30% of bone marrow (e.g., whole pelvis, half spine), excluding patients who have had total body irradiation as part of a conditioning regimen for ASCT;

• Major surgery within 2 weeks of study entry;

• Previous allogeneic stem cell transplant;

• Inadequate bone marrow or other organ function as evidenced by:

• Hemoglobin <9 g/dL (transfusions and/or erythropoietin are permitted);

• Absolute neutrophil count (ANC) ≤1.0 × 109 cells/L [patients with neutropenia (ANC 1-1.5) as a function of their disease may be supported with granulocyte-colony stimulating factor (G-CSF)];

• Platelet count <100 × 109 cells/L or platelet count <75 × 109 cells/L if bone marrow disease involvement is documented;

• Total bilirubin >2.0 × upper limit of normal (ULN) or >3.0 × ULN in the presence of demonstrable liver metastases;

• Aspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) >2.0 × ULN or >3.0 × ULN in the presence of demonstrable liver metastases; or

• Serum creatinine >2.0 × ULN;

• Patients who are pregnant or breast-feeding;

• Coexistent second malignancy or history of prior solid organ malignancy within previous 3 years (excluding basal or squamous cell carcinoma of the skin, and in situ carcinoma of the cervix (CIN 1) that has been treated curatively);

• Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures; or

• Prior exposure to romidepsin (other HDAC inhibitors are allowed).

Trial Contact Information

Trial Lead Organizations/Sponsors

Gloucester Pharmaceuticals

Jean Nichols, Ph.D.

Study Director

Susan Carroll		Ph: 917-848-2289
		Email: susan.carroll@gloucesterpharma.com

U.S.A.
California
	LaJolla
	Rebecca and John Moores UCSD Cancer Center
		Lonna Matthews	Ph: 858-822-5363
			Email: lmatthews@ucsd.edu
	Los Angeles
	Jonsson Comprehensive Cancer Center at UCLA
		Donna Fernando	Ph: 310-794-4376
			Email: Dfernando@mednet.ucla.edu
Colorado
	Denver, Boulder, Aurora, Colorado Springs, etc.
	Rocky Mountain Cancer Center-12 locations in CO
		Mary Rauch	Ph: 832-348-5947
			Email: Mary.Rauch@USOncology.com
Connecticut
	New Haven
	Yale Cancer Center
		Donna Lacivita	Ph: 203-737-2579
			Email: donna.lacivita@yale.edu
District of Columbia
	Washington
	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
		Parichehr Ramzi	Ph: 202-687-6185
			Email: ramzip1@georgetown.edu
Florida
	Orlando, Ocoee, Winter Park, Kissimmee
	Cancer Centers of Florida - Orlando
		Mary Rauch	Ph: 832-348-5947
			Email: Mary.Rauch@USOncology.com
	Tampa
	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
		Jennifer Paleveda Peña	Ph: 813-745-5413
			Email: Jennifer.Paleveda@moffitt.org
Georgia
	Atlanta
	Winship Cancer Institute of Emory University
		Heather Renfroe	Ph: 404-778-5127
			Email: hrenfro@emory.edu
	Augusta
	Augusta Oncology Associates - Walton Way
		Marnie Brotherton, RN, OCN	Ph: 901-259-3233
			Email: mbrotherton@sosacorn.com
	Macon
	Central Georgia Cancer Care, PC - Macon
		Marnie Brotherton, RN, OCN	Ph: 901-259-3233
			Email: mbrotherton@sosacorn.com
Illinois
	Arlington Heights, Niles, Winfield
	Northwest Medical Specialists, PC
		Mary Rauch	Ph: 832-348-5947
			Email: Mary.Rauch@USOncology.com
	Chicago
	Rush Cancer Institute at Rush University Medical Center
		Wendy Mallon	Ph: 312-563-2140
			Email: Wendy_Mallon@rsh.net
Maryland
	Baltimore
	St. Agnes Hospital Cancer Center
		Carole Miller, M.D.	Ph: 410-368-3414
			Email: cmiller@stagnes.org
	Bethesda
	Center for Cancer and Blood Disorders
		Ralph Boccia, MD	Ph: 301-571-0019
			Email: bocciar@comcast.net
	NCI - Center for Cancer Research
		Robin Frye	Ph: 301-402-5958
			Email: fryer@mail.nih.gov
Missouri
	St. Louis, Washington
	Arch Medical Services, Incorporated at Center for Cancer Care and Research
		Mary Rauch	Ph: 832-348-5947
			Email: Mary.Rauch@USOncology.com
Nebraska
	Omaha
	Methodist Estabrook Cancer Center
		Marlene Watson, RN BN	Ph: 402-354-5831
			Email: marlene.watson@nmhs.org
New Jersey
	Hackensack
	Hackensack University, The Cancer Center at HUMC
		Peggy L. Ford, MSN, RN	Ph: 201-996-2000 Ext.66488
			Email: pford@humed.com
New York
	New York
	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
		Shannon Serwich	Ph: 212-342-3590
			Email: sms129@columbia.edu
	Memorial Sloan-Kettering Cancer Center
		Hanna Weissbrot	Ph: 646-227-2139
			Email: weissbrh@mskcc.org
	New York Weill Cornell Cancer Center at Cornell University
		Karen Weil	Ph: 212-746-1858
			Email: kew2009@med.cornell.edu
Oregon
	Portland
	Northwest Cancer Specialists - Northwest Office
		Mary Rauch	Ph: 832-348-5947
			Email: Mary.Rauch@USOncology.com
Texas
	Dallas
	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
		Tracee Rainey,, RN, BSN	Ph: 214-648-5102
			Email: tracee.rainey@utsouthwestern.edu
	El Paso
	Texas Oncology, PA at El Paso Cancer Treatment Center - West
		Mary Rauch	Ph: 832-348-5947
			Email: Mary.Rauch@USOncology.com
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Linda Lacerte	Ph: 713-792-1044
			Email: llacerte@mdanderson.org
	San Antonio
		Swaminathan Padmanabhan, MD	Principal Investigator
	University of Texas Health Science Center at San Antonio
		Stephanie Hodges	Ph: 210-450-1804
			Email: HodgesS@uthscsa.edu
Washington
	Seattle
	Fred Hutchinson Cancer Research Center
		Fereshteh Assadian	Ph: 206-667-5616
			Email: fassadia@fhcrc.org
	Vancouver
	Northwest Cancer Specialists at Vancouver Cancer Center
		Mary Rauch	Ph: 832-348-5947
			Email: Mary.Rauch@USOncology.com
Australia
	Melbourne
	St. Vincent's Hospital - Melbourne
		Bridget Ady	Ph: 61 3 9288 3168
			Email: Bridget.ADY@svhm.org.au
	St. Leonards
	Royal North Shore Hospital
		Molly Forbes	Ph: +61 2 9926-6020
Victoria
	East Melbourne
	Peter MacCallum Cancer Centre
		Glenda Burke	Ph: +61 3 9656 1111
			Email: Glenda.Burke@petermac.org
Czech Republic
	Brno
	Faculty Hospital Brno
		David Salek, Dr.	Ph: : +420 532 233 642
			Email: dsalek@email.cz
	Hradec Kralove
	Fakultni Nemocnice Hradec Kralove
		Belada , Dr	Ph: +420 49 583 3846
			Email: david.belada@seznam.cz
	Praha
	First Medical Clinic of Charles University Hospital
		Klara Hruba	Ph: +420 224 963 117
			Email: hruba@lymphoma.cz
	University Hospital Kralovske Vinohrady
		Kozak , Dr	Ph: +420 267 162 292
			Email: kozak@fnkv.cz
France
	Lyon
	Centre Hospitalier Lyon Sud
		Mrs. Ouafae El Fouiker	Ph: +33 (0) 478864337
			Email: ouafae.el-fouiker@chu-lyon.fr
	Nanates
	CHR Hotel Dieu
		Thomas Gastinne	Ph: +33 2 40 08 33 02
			Email: Thomas.GASTINNE@chu-nantes.fr
	Pessac
	Hopital Haut Leveque
		Frederic Perry	Ph: +33 (0) 557656018
			Email: frederic.perry@chu-bordeaux.fr
	Rennes Cedex
	Centre Hospitalier Universitaire de Rennes
		Corrine Picouleau	Ph: +33 (0) 2 99 28 96 33
			Email: hematorc.hematorc@chu-rennes.fr
	Rouen Cedex
	Centre Henri Becquerel
		Herve Tilly	Ph: =33 (0) 2 32 08 22 23
			Email: htilly@rouen.fnclcc.fr
Germany
	Berlin
	Charite University Hospital - Campus Virchow Klinikum
		Margrit Stodder	Ph: +49-450-553-862
			Email: margrit.stodder@charite.de
	Frankfurt
	Krankenhaus Nordwest
		Eckhart Weidmann, MD	Ph: +49 (0) 69 7601-1
			Email: weidmann.eckhart@khnw.de
	Koeln
	Medizinische Universitaetsklinik I at the University of Cologne
		Marcel Reiser, MD	Ph: +49 (0) 221 478 4408
			Email: Marcel.Reiser@uni-koeln.de
	Muenchen
	Klinikum der Universitat Muenchen-Grosshadem
		Martin Dreyling, Prof.	Ph: +49 89 7095 2202
			Email: martin.dreyling@med.uni-muenchen.de
	Nurnberg
	Institut fur medizinische Onkologie und Hamatologie
		Roswitha Munch	Ph: +49-911-398-3887
			Email: muench@klinikum-nuernberg.de
Poland
	Gdansk
	Klinika Hematologii i Transplantologii, Akademickie Centrum Klinikczne
		Andrzej Hellmann, Prof	Ph: +48 58 349 22 30
			Email: klhem@amg.gda.pl
	Krakow
	Kliniczny Kliniki Hematologii Szpitala Uniwersyteckiego w Krakowie
		Aleksander Skotnicki, Prof.
			Email: alekskot@cm-uj.krakow.pl
	Lodz
	Klinika Hematologii UM, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
		Tadeusz Robak, Prof	Ph: +48 42 689 51 91
			Email: robaktad@csk-unmed.lodz.pl
	Warszawa
	Nowotworów Ukladu Chlonnego, Centrum Onkologii-Instytutu im. Marii Sklodowskiej-Curie
		Jan Walewski, MD, PhD	Ph: +48 22 546 22 23
			Email: walewski@coi.waw.pl
Spain
	Barcelona
	Vall d'Hebron University Hospital
		Oriol Olive	Ph: +34 93 27 46 100 Ext.4375
			Email: oolive@vhebron.net
	Madrid
	Hospital de la Princesa
		Alberto P Barbero	Ph: +34 91 520 22 00 Ext.3284
			Email: pliegoalberto@yahoo.com
	Hospital Universitario La Paz
		Raquel Gi Gil	Ph: +34 91 727 71 16
			Email: raquelajg@hotmail.com
	Pamplona
	Clinica Universitaria
		Miren Remen	Ph: +34 94 825 54 00
			Email: mremon@unav.es
	Salamanca
	University Hospital - Salamanca
		Magdalena Garcia	Ph: +34 923 291 316
	Valdecilla
	Hospital Universitario Marques de Valdecilla
		Ana Floranes	Ph: +34 942 20 34 50
Sweden
	Lund
	Lund University Hospital
		Thomas Relander, Dr.	Ph: +46 46 17 75 20
			Email: thomas.relander@med.lu.se
	Uppsala
	Uppsala University Hospital
		Hans Hagberg, Prof.	Ph: +46 18 611 0000 or 46 18
			Email: hans.hagberg@akademiska.se
Ukraine
	Dnipropetrovsk
	Dnipropetrovsk State Medical Academy
		Igor Bondarenko, Prof	Ph: +38 056 741 74 18
			Email: oncology@dsma.dp.ua
	Kyiv
	R.E.Kavetsky Institute of Experimental Pathology, Oncology and Radiobiology of National Academy of Sciences of Ukraine, Kyiv city oncological hospital
		Olga Ponomarova, MD, PhD	Ph: +38 044 257 96 44
			Email: pola59@rambler.ru
	Lviv
	Institute of Blood Pathology and Transfusion medicine of AMS Ukraine, Communal City Clinical Hospital #5 of City Lviv
		Yaroslava Vyhovska, Prof.	Ph: : +38 032 238 11 70
			Email: tsiapka@yandex.ru
United Kingdom
	London
	Catherine Lewis Centre
		Lorraine Armstrong	Ph: +44 (0) 20 8383 8553
			Email: l.armstrong@imperial.ac.uk
	Guy's Hospital
		Kylie Gyertson	Ph: +44 (0)20 7188 7188 Ext.81430
			Email: kylie.gyertson@gstt.nhs.uk

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00426764
Information obtained from ClinicalTrials.gov on April 16, 2009